NCT03625375

Brief Summary

Dysmenorrhea is one of the most common gynecological problem in adolescents and young women. Symptoms of dysmenorrhea include pelvic / abdominal pain, back pain, headache, nausea, vomiting, diarrhea. These symptoms occur before menstrual bleeding or with bleeding and lasts in 12-74 hours. The objective of this study to investigate the effects of combined exercises on dysmenorrhea symptoms. Exercise protocol aerobic, stretching, kegels, pelvic motions and relaxation exercises.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2018

Completed
16 days until next milestone

Study Start

First participant enrolled

June 20, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 10, 2018

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

September 27, 2018

Status Verified

September 1, 2018

Enrollment Period

2 months

First QC Date

June 4, 2018

Last Update Submit

September 26, 2018

Conditions

Keywords

exercise

Outcome Measures

Primary Outcomes (1)

  • pain changes from baseline to 8 weeks

    to asses pain level with Visual Analogue Scale. 0 means no pain. Higher points means higher pain.

    To asses pain level changes in this study assement make at baseline and repeat after 1 and 2 months

Secondary Outcomes (2)

  • menstrual symptoms changes from baseline to 8 weeks

    At baseline, after 4 weeks from baseline and 8 weeks after baseline

  • sleep quality changes from baseline to 8 weeks

    At baseline of the study, after 4 weeks from baseline and 8 weeks after baseline

Study Arms (2)

Treatment Group

EXPERIMENTAL

Individuals will perform exercises 3 times a week.

Other: Exercise

Control Group

NO INTERVENTION

Individuals will not perform exercises

Interventions

Intervention consist of aerobic, stretchig, pelvic motions, kegels and relaxation exercises

Treatment Group

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The Visual Analogue Scale value is at least 5 per day when the dysmenorrhea symptoms are the most painful,
  • To have the regular menstrual cycle (24-35 days),
  • Being a sedentary (not participating in any regular exercise program).

You may not qualify if:

  • Women with secondary dysmenorrhea,
  • The women who gave birth or abortion,
  • People with active sexual experience,
  • Women who use intrauterine devices,
  • Individuals with regular drug use,
  • Serious psychological problems
  • Acute musculoskeletal problems,
  • People with neurological or cardiopulmonary disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Mediterranean University

Famagusta, 99450, Cyprus

RECRUITING

Related Publications (1)

  • Kirmizigil B, Demiralp C. Effectiveness of functional exercises on pain and sleep quality in patients with primary dysmenorrhea: a randomized clinical trial. Arch Gynecol Obstet. 2020 Jul;302(1):153-163. doi: 10.1007/s00404-020-05579-2. Epub 2020 May 15.

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Berkiye Kırmızıgil

    Eastern Meditteranean University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2018

First Posted

August 10, 2018

Study Start

June 20, 2018

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

September 27, 2018

Record last verified: 2018-09

Locations